‘More than 2,000’ US lawsuits for Boehringer
pharmafile | February 14, 2014 | News story | Sales and Marketing | Boehringer, Pradaxa, Xarelto, blood thinner, warfarin
Boehringer Ingelheim is facing more than 2,000 lawsuits in the US over allegations that its stroke prevention pill Pradaxa has caused severe or fatal bleeding.
In an email to Pharmafocus, a Boehringer spokesman said: “This is not an unusual phenomenon when it comes to US litigation. We are confident of demonstrating that we have worked very carefully and responsibly in research, development and marketing of our medicine.”
The drug is one of three new oral blood thinners – along with Bayer’s Xarelto and Pfizer/Bristol-Myers Squibb’s Eliquis – looking to replace the 50-year old treatment warfarin.
Pradaxa (dabigatran) was approved in 2011, and its rapid uptake in the US was one of the factors which helped Boehringer enjoy a strong 2012.
The drug was then well set as a long-term engine for growth – however, bleeding is a well-known complication of all anticoagulant medicines, with their ability to prevent strokes and thus save lives balanced against the side effect of causing internal bleeding.
“The clinical evidence for Pradaxa is clear,” the Boehringer spokesman continues. “The efficacy and safety was established in one of the largest stroke prevention clinical trials ever conducted with patients with non-valvular atrial fibrillation involving more than 18,000 patients.”
Both the EMA and FDA have recently reaffirmed the positive risk/benefit profile of Pradaxa.
“Also the last Minisentinel analysis done by the FDA in Dec 2012 and published in April 2013 showed that there is no greater bleeding risk for Pradaxa than for warfarin,” the spokesman concludes. “We are confident that also the new Minisentinel analysis will confirm the positive risk/benefit result.”
The EMA looked into post-marketing studies of the drug after high rates of bleeding were seen in some Phase III clinical trials.
Boehringer itself said that 260 cases of fatal bleeding have been linked to Pradaxa in post-marketing studies – but the frequency of occurrence was still significantly lower than that observed in the clinical trials that supported the drug’s approval.
The EMA suggested making advice to doctors and patients clearer – including more specific guidance on when Pradaxa must not be used, as well as advice on managing patients and reversing the anticoagulant effect of Pradaxa if bleeding occurs.
There have been other safety concerns around Pradaxa, with the EMA telling Boehringer it must alert doctors to check their patient’s kidney functions prior to using the drug.
This is because Pradaxa is mainly excreted renally, meaning that the treatment should not be prescribed to patients with severe renal impairment.
Adam Hill
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